Description and Brand Names

US Brand Name

A-Caro-25

Lumitene

Descriptions

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Beta-carotene is converted in the body to vitamin A, which is necessary for healthy eyes and skin.

A lack of vitamin A may cause a rare condition called night blindness (problems seeing in the dark). It may also cause dry eyes, eye infections, skin problems, and slowed growth. Your health care professional may treat these problems by prescribing either beta-carotene, which your body can change into vitamin A, or vitamin A for you.

Some conditions may increase your need for vitamin A. These include:

Cystic fibrosis

Diarrhea, continuing

Illness, long-term

Injury, serious

Liver disease

Malabsorption problems

Pancreas disease

Increased need for vitamin A should be determined by your health care professional.

Claims that beta-carotene is effective as a sunscreen have not been proven. Although beta-carotene supplements are being studied for their ability to reduce the risk of certain types of cancer and possibly heart disease, there is not enough information to show that this is effective.

Beta-carotene may be used to treat other conditions as determined by your doctor.

Beta-carotene is available without a prescription.

Once a product has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, beta-carotene is used in certain patients with the following medical conditions:

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

It is documented that people who consume diets high in fruits and vegetables have a reduced risk of heart disease and certain cancers. Fruits and vegetables are rich in beta-carotene and other nutrients that may be beneficial.

Beta-carotene is found in carrots; dark-green leafy vegetables, such as spinach and green leaf lettuce; sweet potatoes; broccoli; cantaloupe; and winter squash. The body converts beta-carotene into vitamin A. Ordinary cooking does not destroy beta-carotene.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body needs other substances found in food, such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, some fat is needed so that beta-carotene can be absorbed into the body.

This product is available in the following dosage forms:

Capsule

Capsule, Liquid Filled

Liquid

Tablet

Before Using

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been documented with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been documented with intake of normal daily recommended amounts.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this dietary supplement. Make sure you tell your doctor if you have any other medical problems, especially:

Eating disorders or

Kidney disease or

Liver disease—These conditions may cause high blood levels of beta-carotene, which may increase the chance of side effects

Proper Use

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For use as a dietary supplement:

For oral dosage forms (capsules or chewable tablets):

Adults and teenagers: 6 to 15 milligrams (mg) of beta-carotene (the equivalent of 10,000 to 25,000 Units of vitamin A activity) per day.

Children: 3 to 6 mg of beta-carotene (the equivalent of 5,000 to 10,000 Units of vitamin A activity) per day.

For other uses:

For oral dosage forms (capsules or tablets):

To treat or prevent a reaction to sun in patients with erythropoietic protoporphyria:

Adults and teenagers—30 to 300 milligrams (mg) of beta-carotene (the equivalent of 50,000 to 500,000 Units of vitamin A activity) a day.

Children—30 to 150 mg of beta-carotene (the equivalent of 50,000 to 250,000 Units of vitamin A activity) a day.

To treat or prevent a reaction to sun in patients with polymorphous light eruption:

Adults and teenagers—75 to 180 mg of beta-carotene (the equivalent of 125,000 to 300,000 Units of vitamin A activity) a day.

Children—30 to 150 mg of beta-carotene (the equivalent of 50,000 to 250,000 Units of vitamin A activity) a day.

If you have high blood levels of vitamin A, your body will convert less beta-carotene to vitamin A.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss taking a vitamin for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins. However, if your health care professional has recommended that you take this vitamin, try to remember to take it as directed every day.

If you miss a dose and you are using it as medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Store the dietary supplement in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

Use of beta-carotene has been associated with an increased risk of lung cancer in people who smoke or who have been exposed to asbestos. One study of 29,000 male smokers found an 18% increase in lung cancer in the group receiving 20 mg of beta-carotene a day for 5 to 8 years. Another study of 18,000 people found 28% more lung cancers in people with a history of smoking and/or asbestos exposure. These people took 30 mg of beta-carotene in addition to 25,000 Units of retinol (a form of vitamin A) a day for 4 years. However, one study of 22,000 male physicians, some of them smokers or former smokers, found no increase in lung cancer. These people took 50 mg of beta-carotene every other day for 12 years. If you smoke or have a history of smoking or asbestos exposure, you should not take large amounts of beta-carotene supplements for long periods of time. However, foods that are rich in beta-carotene are considered safe and appear to lower the risk of some types of cancer and possibly heart disease.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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